VITAMIN D INTERVENTION IN INFANTS: Effects of Early Vitamin D Exposure on Childhood Health at 6 Years - a Follow-up Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 415
- 试验地点
- 1
- 主要终点
- Bone mineral density
研究概览
简要总结
Exposure to vitamin D intervention in early life may have permanent effects on physiology and metabolism. Bone growth and mineralization, development of immunity, body composition and brain structure and functioning may be affected. The importance of a long-term surveillance includes follow-up of both beneficial but also harmful effects of vitamin D.
Vitamin D intervention in infants (VIDI) study was conducted in 2013-2016. VIDI study was a large randomized trial that aimed to evaluate effects of two vitamin D supplemental doses of daily 10 ug and 30 ug from the age 2 weeks until 2 years on bone strength, infections, immunity, allergy, atopy and asthma, neurologic and cognitive development, and genetic regulation of mineral homeostasis. Current study is a 6 Years Follow-up (VIDI2) study of the original VIDI trial.
Our focuses of interest in the follow-up are: bone strength, growth pattern, body composition, and morbidity due to infections and allergic diseases, and the development of immunity. Further, in addition to more classical associates of vitamin D, our aim is to continue to follow-up children's neurocognitive development and mental health. We will also focus on the effect of vitamin D supplementation on occurrence of molar-incisor hypomineralization, dental caries, and oral immunity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All who participated in the original VIDI study until last study visit at the age of 2 years.
- •Exclusion criteria:
排除标准
- 未提供
结局指标
主要结局
Bone mineral density
时间窗: 6.5 years
Bone mineral density in grams per centimeter squared is measured by DXA.
Serum intact parathyroid hormone
时间窗: 6.5 years
Serum intact parathyroid hormone concentration is measured from blood samples with the blood gas analyzer ABL 90 FLEX or ABL 835 FLEX.
Plasma alkaline phosphatase
时间窗: 6.5 years
Plasma alkaline phosphatase concentration is measured from blood samples with photometric methods.
Height
时间窗: 6.5 years
.Height in centimeters is measured with a Seca 285 digital measuring station
Areal bone mineral quantity
时间窗: 6.5 years
Bone mineral quantity in milligrams per millimeter is measured by peripheral quantitative computed tomography (pQCT).
Cross-sectional area of the bone
时间窗: 6.5 years
Cross-sectional area of the bone in square millimeters is measured by pQCT.
Bone mineral quantity
时间窗: 6.5 years
Bone mineral quantity in grams is measured by dual-energy X-ray absorptiometry (DXA).
Serum C-telopeptide of type I collagen
时间窗: 6.5 years
Serum C-telopeptide of type I collagen is measured with competitive polyclonal antibody assay.
Plasma fibroblast growth factor 23
时间窗: 6.5 years
Plasma intact and C-terminal fibroblast growth factor 23 is determined with enzyme-linked immunosorbent assay.
Morbidity due to infectious diseases
时间窗: 6.5 years
Morbidity due to infectious diseases in frequencies and type are to be collected via questionnaires filled in by parents.
Morbidity due to allergic diseases
时间窗: 6.5 years
Morbidity due to allergic diseases and symptoms are to be collected via questionnaires filled in by parents.
Fat mass
时间窗: 6.5 years
Fat mass in kilograms based on ohms is measured by InBody bioelectrical impedance analysis.
Fat-free mass
时间窗: 6.5 years
Fat-free mass in kilograms based on ohms is measured with InBody.
Volumetric bone mineral density
时间窗: 6.5 years
Bone mineral density in milligrams per cubic centimeter is measured by pQCT.
Plasma ionized calcium
时间窗: 6.5 years
Plasma ionized calcium concentration is measured from blood samples with the blood gas analyzer ABL 90 FLEX or ABL 835 FLEX.
Weight
时间窗: 6.5 years
Weight in kilograms is measured with a Seca 285 digital measuring station.
次要结局
- High sensitivity C-reactive protein(6.5 years)
- Cognitive abilities(6.5 years)
- Autism spectrum disorders and symptoms(6.5 years)
- Temperament(6.5 years)
- Prevalence of caries(6.5 years)
- Gene variants(6.5 years)
- Salivary matrix metalloproteinase 8 level(6.5 years)
- Epigenetic changes(6.5 years)
- Psychiatric disorders and symptoms(6.5 years)
- Executive functioning(6.5 years)
- Prevalence of molar-incisor hypomineralization(6.5 years)
- Plasma matrix metalloproteinase 8(6.5 years)
- Attention deficient and hyperactivity symptoms(6.5 years)
- Sleep(6.5 years)
- SARS-CoV-2 virus antibodies(6,.5 years)
- SARS-CoV-2 virus(6.5 years)
研究者
Sture Andersson
Professor Sture Andersson
University of Helsinki